Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine

NCT04600388 | Completed FDA Device

• 1 other identifier: TCH009
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Post-marketing, retrospective, observational survey study. Users (menstruating women only) of Nerivio who have used Nerivio at least 4 times between October 2019 and December 2020 will be contacted by email and/or through an app notification and will be asked to complete a 5-minute online anonymous survey assessing satisfaction, effectiveness, and safety. Eligible users will sign an informed consent form (the consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page) and complete a survey asking about their satisfaction with Nerivio and the effectiveness and safety of the device for acute treatment of menstrual migraine. During the survey, participants will be screened to verify that they have menstrual migraine (self-reported) and have used Nerivio to treat menstrual migraines.

Conditions

Menstrual Migraine

Outcome Measures

Primary Outcomes (2)

• Efficacy of Nerivio during menstrual migraines

  Efficacy of Nerivio for headache relief during menstrual migraines rated on a 5-point Likert scale (1 - Not at all effective, 2 - Slightly effective, 3 - Moderately effective, 4 - Very effective, 5- Extremely effective)

  3 months

• Satisfection of using Nerivio during menstrual migraines

  Satisfection of using Nerivio during menstrual migraines rated on a 5-point Likert scale )1 - Not at all satisfied, 2 - Slightly dissatisfied, 3 - Neutral, 4 - Slightly satisfied, 5 -Extremely satisfied)

  3 months

Secondary Outcomes (3)

• Mean headache relief

  3 months

• Medication consumption

  3 months

• Reduction of menstrual cramps

  3 months

Interventions

Nerivio DEVICE

Nerivio Remote Electrical Neuromodulation (REN) device

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Menstrual migraine is female only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Menstruating women aged 18-55 years who have used Nerivio at least 4 times and have menstrual migraine.

You may qualify if:

• Women aged 18-55 years
• Participants have used Nerivio at least 4 times
• Participants experience menstrual migraines (pure menstrual migraine or menstrually-related migraine; self-reported)
• Participants have used Nerivio to treat menstrual migraine

You may not qualify if:

• \. Non-menstruating women

Sponsors & Collaborators

• Theranica: lead

Study Sites (1)

Vassar Ambulatory Surgical Center

Poughkeepsie, New York, 12601, United States

Location

Related Publications (1)

• Nierenburg H, Rabany L, Lin T, Sharon R, Harris D, Ironi A, Wright P, Chuang L. Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability. Pain Ther. 2021 Dec;10(2):1245-1253. doi: 10.1007/s40122-021-00276-7. Epub 2021 Jun 17.

  PMID: 34138449 DERIVED

Study Officials

• Hida Nierenburg, MD

  Nuvance Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: September 9, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 10, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)